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DV3395 C1

Phase 1

Healthy Volunteers, Medical Device | Unknown | Other |Novo Nordisk A/S|Last Updated: Nov 19, 2024

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment65
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05314283A Study Investigating the Safety and Performance of DV3395, a New Concept Device for the Delivery of Medicine.PHASE1 COMPLETED 65 — — Mar 28, 2022Nov 8, 2022Nov 19, 20241 Netherlands
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Study Endpoints
Primary Endpoints
Number of adverse events
From exposure (defined as when the participant takes DV3395-C1 into his/her hand with the intention of swallowing it) to DV3395 C1 on day 1 (visit 2) to 7 days after excretion of DV3395 C1 (phone visit 3, expected between day 9 and day 12)

Number of events

Secondary Endpoints
Confirmed DV3395 C1 integrity upon excretion (yes/no)
On day of excretion of DV3395 C1 (visit 2, expected between day 2 and day 5)
Confirmed gastric activation of DV3395 C1 (yes/no)
From administration (defined as when the participant places DV3395-C1 in his/her mouth with the intention of swallowing it) of DV3395 C1 on day 1 (visit 2) to time of last image approximately 5 hours later on day 1 (visit 2)
Time to activation of DV3395 C1
From administration (defined as when the participant places DV3395-C1 in his/her mouth with the intention of swallowing it) of DV3395 C1 on day 1 (visit 2) to time of last image approximately 5 hours later on day 1 (visit 2)
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeOTHER
Treatment Arms
ArmTypeDescription
DV3395 C1EXPERIMENTAL -
Interventions
NameTypeDescription
DV3395 C1DEVICEParticipants will be exposed to and swallow DV3395 C1 once. The participants will stay at the clinic research center for up to 6 days .
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion criteria: * Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator. * Body mass index between 18.5 and 29.9 k...

Countries:Netherlands
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